(255 days)
The DEFENDO™ FUJIFILM™ 500/600 Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure.
The DEFENDO™ FUJIFILM™ 500/600 Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure.
The DEFENDO™ FUJIFILM™ 500/600 Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The ENDOGATOR™ FUJIFILM™ 500/600 Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).
The Defendo Fujifilm 500/600 Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single use valves designed to be used on the Fujifilm 500/600 series GI endoscopes as accessories. The specific valves include the Defendo Fujifilm 500/600 Single Use Air/Water Valve, the Defendo Fujifilm 500/600 Single Use Suction Valve, the Defendo Fujifilm 500/600 Single Use Biopsy Valve, and the Endoqator Fujifilm 500/600 Single Use Connector.
The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure.
The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure.
The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures.
The Connector allows attachment between the irrigation tube set via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water iet valve.
These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.
The provided FDA 510(k) summary (K232067) describes the acceptance criteria and the study that proves the device meets those criteria for the Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, and Endogator Fujifilm 500/600 Single Use Connector.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide explicit numerical acceptance criteria for each test. Instead, it states that "non-clinical performance testing was performed on the subject device to support the substantial equivalence determination" and concludes that the device "has shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use." This implies that the performance of the new devices was within acceptable ranges compared to the predicate devices or met internal engineering specifications for each test.
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Air/Water Valve | ||
| Gas (Air and CO2) flow rate testing | Performance comparable to predicate or acceptable flow rates | Met acceptance criteria (implied by overall conclusion) |
| Water flow rate testing | Performance comparable to predicate or acceptable flow rates | Met acceptance criteria (implied by overall conclusion) |
| Backflow prevention testing | Effective backflow prevention comparable to predicate | Met acceptance criteria (implied by overall conclusion) |
| Mechanical testing (Depression Force, Valve Application Force, Valve Removal Force, Force to Disassemble via Axial Pull) | Mechanical forces comparable to predicate or within specifications | Met acceptance criteria (implied by overall conclusion) |
| Button Cycling | Durable operation over repeated cycles comparable to predicate | Met acceptance criteria (implied by overall conclusion) |
| Suction Valve | ||
| Suction Bypass | Effective suction bypass comparable to predicate | Met acceptance criteria (implied by overall conclusion) |
| Suction Rate (water and soil) | Suction rates comparable to predicate or within specifications | Met acceptance criteria (implied by overall conclusion) |
| Mechanical testing (Depression Force, Valve Application Force, Valve Removal Force, Force to Disassemble via Axial Pull) | Mechanical forces comparable to predicate or within specifications | Met acceptance criteria (implied by overall conclusion) |
| Valve Operation / Procedure Duration Test | Durable operation over typical procedure duration | Met acceptance criteria (implied by overall conclusion) |
| Biopsy Valve | ||
| Leak Testing | Minimal leakage comparable to predicate | Met acceptance criteria (implied by overall conclusion) |
| Insufflation Testing | Effective maintenance of insufflation comparable to predicate | Met acceptance criteria (implied by overall conclusion) |
| Auxiliary Waterjet Valve (Connector) | ||
| Flow Durability Testing | Durable flow over repeated use | Met acceptance criteria (implied by overall conclusion) |
| Torque Test | Adequate torque resistance for secure connection | Met acceptance criteria (implied by overall conclusion) |
| Packaging | ||
| ISO 11607/ASTM 4169 (sterile barrier) | Sterile barrier maintained after shipping/transit | Maintained sterile barrier (explicitly stated) |
| Biocompatibility | ||
| ISO 10993-1 (for patient-contacting portions) | Biocompatible as per ISO 10993-1 | Subject devices are biocompatible (explicitly stated) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each non-clinical performance test. It only mentions that "non-clinical performance testing was performed."
The data provenance is from non-clinical performance testing. There is no indication of human data, so country of origin and retrospective/prospective classification are not applicable in this context. These are laboratory/engineering tests performed by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The performance tests are engineering and materials science tests, not clinical evaluations requiring expert interpretation for ground truth. The "ground truth" for these tests would be objective measurements against established technical specifications or predicate device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the studies were non-clinical performance tests, not clinical evaluations requiring adjudication of subjective assessments. The results would be objective measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is a single-use valve/connector for endoscopes, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a mechanical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these non-clinical performance tests would be objective measurements against established technical specifications or the performance of the legally marketed predicate devices. For example, a flow rate test would have a specified minimum/maximum flow, or a leak test would have a maximum allowable leak rate. Biocompatibility utilized ISO 10993 standards.
8. The sample size for the training set
This information is not applicable. This is a medical device accessory undergoing non-clinical performance testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
March 22, 2024
Medivators (A Subsidiary of STERIS Corporation) Nick Wang Senior Manager, Regulatory Affairs 3150 Pollok Drive Conroe, Texas 77303
Re: K232067
Trade/Device Name: Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: February 22, 2024 Received: February 22, 2024
Dear Nick Wang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
{2}------------------------------------------------
Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K232067
Device Name
Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector
Indications for Use (Describe)
The DEFENDO™ FUJIFILM™ 500/600 Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure.
The DEFENDO™ FUJIFILM™ 500/600 Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure.
The DEFENDO™ FUJIFILM™ 500/600 Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The ENDOGATOR™ FUJIFILM™ 500/600 Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the STERIS logo. The text "K232067 Page 1 of 9" is at the top right of the image. The STERIS logo is in large, bold letters. Below the STERIS logo is a graphic of several horizontal wavy lines.
510(k) Summary
Defendo Fujifilm 500/600 Single Use Valve Set
| Manufacturer: | Medivators |
|---|---|
| 3150 Pollok Drive | |
| Conroe, TX 77303 | |
| Submitter: | Nick Wang, Ph D., RA |
- Nick Wang, Ph.D., RAC Submitter: Senior Manager, Regulatory Affairs Phone: 440-392-7482
- Summary Date: 14 March 2024
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "STERIS" in large, bold, sans-serif font. Above the word "STERIS" is the text "K232067 Page 2 of 9". Below the word "STERIS" is an image of several horizontal lines that are stacked on top of each other. The lines are blue and white.
1. Device Name
| Trade Name: | Defendo Fujifilm 500/600 Single Use ValvesSet |
|---|---|
| Device Classification: | Class II |
| Common/usual Name: | Defendo Fujifilm 500/600 Single Use Air/WaterValve, Defendo Fujifilm 500/600 Single UseSuction Valve, Defendo Fujifilm 500/600Single Use Biopsy Valve, Endogator Fujifilm500/600 Single Use Connector |
| Classification Name: | Endoscope and Accessories |
| Classification Number: | 21 CFR 876.1500 |
| Product Code: | ODC |
2. Predicate Device(s)
Primary predicate is listed first:
K102409 - Defendo Disposable Air/Water Valve Model 100304 K102581 - Defendo Disposable Suction Valve Model 100305 K090851 - Defendo Biopsy Valves K220395 - Endogator Endoscopy Irrigation Tubing
3. Description of Device
The Defendo Fujifilm 500/600 Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single use valves designed to be used on the Fujifilm 500/600 series GI endoscopes as accessories. The specific valves include the Defendo Fujifilm 500/600 Single Use Air/Water Valve, the Defendo Fujifilm 500/600 Single Use Suction Valve, the Defendo Fujifilm 500/600 Single Use Biopsy Valve, and the Endoqator Fujifilm 500/600 Single Use Connector.
- . The Air/Water valve allows the end-user to control and maintain air or CO> insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure.
- . The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure.
{6}------------------------------------------------
- . The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures.
- The Connector allows attachment between the irrigation tube set via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water iet valve.
These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.
4. Intended Use
The DEFENDO™ FUJIFILM™ 500/600 Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The DEFENDO™ FUJIFILM™ 500/600 Single Use Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
The DEFENDO™ FUJIFILM™ 500/600 Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The ENDOGATOR™ FUJIFILM™ 500/600 Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).
5. Technological Characteristic Comparison Table
Table 1. Proposed/Predicate Device Technological Characteristics Comparison Table - Air / Water Valve
| Feature | Defendo Fujifilm500/600 Single UseAir/Water Valve(Subject Device) | DefendoDisposableAir/Water Valve(PredicateK102409) | Comparison |
|---|---|---|---|
| Intended use | The DEFENDO™FUJIFILM™ 500/600Single Use Air/WaterValve is intended to beused to control the | The DefendoDisposable Air/WaterValve is intended tobe used to controlthe air/water function | Same |
| Feature | Defendo Fujifilm500/600 Single UseAir/Water Valve(Subject Device) | DefendoDisposableAir/Water Valve(PredicateK102409) | Comparison |
| air/water function onan endoscope during aGI endoscopicprocedure. | on an endoscopeduring a GIendoscopicprocedure. | ||
| Sterile/Non-sterile | Sterile | Sterile | Same |
| SterilizationMethod | EtO | EtO | Same |
| SterilizationAssuranceLevel | 10-6 | 10-6 | Same |
| Usage | Single-Use | Single-Use | Same |
| Main DeviceDimensions(lengths/widths) | Air/Water Valve:Length: ~32.0 mmDiameter: ~16.5 mm | Air/Water Valve:Length: ~46 mmDiameter: ~17 mm | Similar |
| TargetPopulation | Patients undergoing anendoscopic procedure | Patients undergoingan endoscopicprocedure | Same |
| EnergyUsed/Delivered | None | None | Same |
| Method ofApplication | Manual actuation | Manual actuation | Same |
| CompatibleEndoscopes | Fujifilm 500/600 seriesGI endoscope | Olympus endoscope | Reason forthis 510(k) |
| Packaging | Supplied as a kit inPETG Tray with TyvekLid | Supplied individuallyinTyvek Pouch | Packagesystems allmaintainsterile barrier |
{7}------------------------------------------------
Table 2. Proposed/Predicate Device Technological Characteristics Comparison Table – Suction Valve
| Feature | Defendo Fujifilm500/600 Single UseSuction Valve(Subject Device) | Defendo DisposableSuction Valve(Predicate K102581) | Comparison |
|---|---|---|---|
| Intended Use | The DEFENDOTMFUJIFILMTM 500/600Single Use SuctionValve is intended tobe used to control | The DefendoDisposable SuctionValve is intended tobe used to control thesuction function on | Same |
| Feature | Defendo Fujifilm500/600 Single UseSuction Valve(Subject Device) | Defendo DisposableSuction Valve(Predicate K102581) | Comparison |
| the suction functionon an endoscopeduring a Glendoscopicprocedure. | an endoscope duringa GI endoscopicprocedure. | ||
| Sterile/Non-sterile | Sterile | Sterile | Same |
| SterilizationMethod | EtO | EtO | Same |
| SterilizationAssurance Level | 10-6 | 10-6 | Same |
| Usage | Single Use | Single Use | Same |
| Main DeviceDimensions(lengths/widths) | Suction Valve:Length: ~29.1 mmDiameter: ~17.1 mm | Suction Valve:Length: ~27 mmDiameter: ~18 mm | Similar, theslightdifferencesare due tothedifferencesin theendoscopeport. |
| Target Population | Patients undergoingan endoscopicprocedure | Patients undergoingan endoscopicprocedure | Same |
| EnergyUsed/Delivered | None | None | Same |
| Method ofApplication | Manual actuation | Manual actuation | Same |
| CompatibleEndoscopes | Fujifilm 500/600series GI endoscope | Olympus endoscope | Reason forthis 510(k) |
| Packaging | Supplied as a kit inPETG Tray withTyvek Lid | Supplied individuallyinTyvek Pouch | Packagesystems allmaintainsterile barrier |
{8}------------------------------------------------
{9}------------------------------------------------
Table 5-3. Proposed/Predicate Device Technological Characteristics Comparison Table – Biopsy Valve
| Feature | Defendo Fujifilm500/600 Single UseBiopsy Valve(Subject Device) | Defendo BiopsyValve (for Olympusand FujinonEndoscopes)(PredicateK090851) | Comparison |
|---|---|---|---|
| Intended Use | The DEFENDO™FUJIFILM™ 500/600Single Use BiopsyValve is intended forcovering theendoscope biopsyport during anendoscopyprocedure. The singleuse Biopsy Valveprovides access forendoscopic devicepassage andexchange, helpmaintain sufflation,and minimize leakageof biomaterial fromthe biopsy portthroughout theendoscopicprocedure. | The Defendo BiopsyValve is intended forcovering theendoscope biopsyport during anendoscopyprocedure. The valveprovides access forendoscopic devicepassage andexchange, helpmaintain sufflation,and minimizeleakage ofbiomaterial from thebiopsy portthroughout theendoscopicprocedure. | Same |
| Sterile/Non-sterile | Sterile | Sterile | Same |
| SterilizationMethod | EtO | EtO | Same |
| SterilizationAssuranceLevel | 10-6 | 10-6 | Same |
| Usage | Single Use | Single Use | Same |
| Main DeviceDimensions(lengths/widths) | Length: ~17.8 mmDiameter: ~15.8 mm | Length: ~17 mmDiameter: ~17 mm | Similar, minordifferences didnot affectperformance(confirmedthrough testing) |
| TargetPopulation | Patients undergoingan endoscopicprocedure | Patients undergoingan endoscopicprocedure | Same |
| Energy Used/Delivered | None | None | Same |
| Feature | Defendo Fujifilm500/600 Single UseBiopsy Valve(Subject Device) | Defendo BiopsyValve (for Olympusand FujinonEndoscopes)(PredicateK090851) | Comparison |
| CompatibleEndoscopes | Olympus and Fujifilmendoscope | Olympus and Fujinonendoscopes | Same |
| Packaging | Continue to besupplied individually inTyvek Pouch(predicate) andsupplied as a set inPETG Tray with TyvekLid (new). | Supplied individuallyinTyvek Pouch | Packagesystems allmaintain sterilebarrier |
{10}------------------------------------------------
Table 5-4. Proposed/Predicate Device Technological Characteristics Comparison Table - Connector
| Feature | Endogator Fujifilm500/600 Single UseConnector(Subject Device) | EndogatorConnector(K092429) | Comparison |
|---|---|---|---|
| Intended Use | The ENDOGATOR™FUJIFILM™ 500/600Single Use Connectoris intended to be usedin conjunction withEndogator IrrigationTubing to provideirrigation via sterilewater during GIendoscopicprocedures whenused with an irrigationpump (or cauteryunit). | The Endogatorsystem is intendedto provide irrigationvia sterile watersupply during GIendoscopicprocedure whensued in conjunctionwith an irrigationpump (or cauteryunit). | Similar(Languagemodified forthe subjectdevice toreflect theconnectorprovided doesnot include theEndogatortubing) |
| Sterile/Non-sterile | Sterile | Sterile | Same |
| SterilizationMethod | EtO | EtO | Same |
| SterilizationAssurance Level | 10⁻⁶ | 10⁻⁶ | Same |
| Usage | Single Use | Single Use | Same |
{11}------------------------------------------------
| Feature | Endogator Fujifilm500/600 Single UseConnector(Subject Device) | EndogatorConnector(K092429) | Comparison |
|---|---|---|---|
| Main DeviceDimensions(lengths/widths) | Length: ~22 mmDiameter: ~12.7 mm | Length: ~22 mmDiameter: ~12.7 mm | Same |
| Target Population | Patients undergoingan endoscopicprocedure | Patients undergoingan endoscopicprocedure | Same |
| EnergyUsed/Delivered | None | None | Same |
| CompatibleEndoscopes | Fujifilm 500/600 seriesGI endoscope | None specified(commonly usedwith Fujifilmendoscopes) | Same |
| Packaging | Continue to besupplied individually inTyvek Pouch(predicate) andsupplied as a set inPETG Tray with TyvekLid (new). | Supplied individuallyin Tyvek Pouch | Packagesystems allmaintainsterile barrier |
4. Non-Clinical Performance Testing
Non-clinical performance testing was performed on the subject device to support the substantial equivalence determination. The following tests were performed:
Air / Water Valve
- Gas (Air and CO2) flow rate testing ●
- Water flow rate testing
- Backflow prevention testing ●
- Mechanical testing ●
- o Depression Force
- O Valve Application Force
- o Valve Removal Force
- o Force to Disassemble via Axial Pull
- Button Cycling ●
Suction Valve
- Suction Bypass ●
- Suction Rate (water and soil) .
{12}------------------------------------------------
- Mechanical testing ●
- Depression Force O
- Valve Application Force O
- Valve Removal Force O
- Force to Disassemble via Axial Pull o
- Valve Operation / Procedure Duration Test ●
Biopsy Valve
- Leak Testing
- . Insufflation Testing
Auxiliary Waterjet Valve (Connector)
- Flow Durability Testing .
- . Torque Test
In addition to performance testing, ISO 11607/ASTM 4169 testing was completed to ensure the packaging of the subject device kit maintained sterile barrier after shipping/transit.
5. Biocompatibility
The biocompatibility of the subject devices was assessed in accordance with the FDA guideline "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Biocompatibility testing conducted on the patient-contacting portions of the subject device in accordance with the ISO 10993 standard. The test result shows that the subject devices are biocompatible.
6. Conclusion
Based on the intended use, technological characteristics, non-clinical performance testing, and biocompatibility assessment, the subject device has shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.